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Utilizing Holmium Laser for FURS Renal Stone Lithotripsy Comparing Stone Breaking vs. Stone Dusting Settings

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Boston Scientific

Status

Terminated

Conditions

Stone Clearance

Treatments

Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

Study type

Interventional

Funder types

Industry

Identifiers

NCT02683993
LUM-SBU-VP-15-01

Details and patient eligibility

About

Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Full description

Twenty (20) subjects presenting with a renal stone and candidates for FURS (flexible ureteroscopic renal surgery) will undergo a single FURS procedure for a kidney stone as part of the study, using the study device. These subjects will be randomized into stone breaking treatment or stone dusting.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Subject will be older than 18 years of age

  2. Subject was diagnosed with renal calculi meeting the following criteria:

    • Largest stone measures no more than 2cm on a single diameter and is no less than 0.8cm as defined by X-ray or CT.
    • Accumulative stone burden (addition of all stone diameters) is no more than 2.5cm.
  3. Subject is a candidate for FURS procedure

  4. Subject is willing and has signed the Informed Consent Form

Exclusion criteria

  1. Subject has undergone a previous treatment for stones in the same kidney
  2. Subject requires another, concomitant procedure, other than FURS, to be performed during this treatment session.
  3. Female subject is pregnant
  4. Concomitant anticoagulant medication that cannot be suspended during surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Stone breaking
Experimental group
Description:
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with low frequency parameters.
Treatment:
Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber
Stone dusting
Experimental group
Description:
Lithotripsy will be performed using the Lumenis Pulse 120H holmium laser system with high frequency parameters.
Treatment:
Device: Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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